Optimization of Golimumab Treatment in Ulcerative Colitis

Hospital de Manises

Status and phase: Unknown; Phase 4

Conditions: Colitis, Ulcerative

Treatments: Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg; Drug: Golimumab treatment optimization.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03669029

JHV-GOL-2018-01

Details and patient eligibility

About

This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after failure (or exposure) to one anti-TNF, which aims to analyze serum golimumab levels and anti- golimumab antibody (ADA) levels during the induction (week 6) and maintenance phases (week 14, 30 and 54) and correlate them with efficacy parameters.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects (18 years or older, both sexes and any race) who will be treated with Golimumab according to clinical criteria.

Exclusion criteria

• Patients with Crohn's disease or colitis pending classification
• Patients with ileoanal pouch
• Patients with perianal fistulas related to the disease
• Patients with a history of hypersensitivity to golimumab, other murine proteins, or to any of the excipients included in the golimumab datasheet.
• Patients with tuberculosis or other serious infections such as septicemia, abscesses and opportunistic infections.
• Patients with moderate or severe heart failure (NYHA grade III / IV)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Week 6 Responders

Experimental group

Description:

In patients with clinical response at week 6, serum golimumab levels and anti-golimumab antibody levels will be correlated with clinical response.

Treatment:

Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg

Week 6 Non Responders

Experimental group

Description:

In patients without clinical response at week 6, golimumab treatment will be optimized.

Treatment:

Drug: Golimumab treatment optimization.